3D Systems (DDD) said Wednesday that it has received the US Food and Drug Administration's 510(k) clearance for its 3D printed Patient-Matched Guides, developed in partnership with Smith+Nephew for use in ankle replacement surgeries.
510(k) clearance indicates that the FDA has determined the device to be safe and effective by comparing it to a legally marketed device already on the market, allowing it to be sold in the US, according to the FDA's website.
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